BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P990009 · Supplement: S072 · Decision Dec 12, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS
    PMA Number
    P990009
    Supplement Number
    S072
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 12, 2023
    Date Received
    November 13, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    change of mold release agent in the manufacture of the syringe and applicator